Topic:   "EIRs, SBIRs, and more with BioHealth Innovation, Inc."

Presenters:

• Richard Bendis, President and CEO
• Ethan Byler, Director, Innovation Programs
• Todd Chappell, Entrepreneur-in-Residence, NIH-OTT
• Dr. Ken Malone, Entrepreneur-in-Residence, UMD Ventures
• Ram Aiyar, Entrepreneur-in-Residence, NHLBI

BioHealth Innovation, Inc. (BHI) is a regional innovation intermediary that accelerates and facilitates technology transfer and commercialization of market-relevant research in federal labs, universities, and biohealth companies in the Region. It is a private-public partnership that connects the Region’s innovation assets to provide integrated technical knowledge, financial means, and entrepreneurial/managerial expertise to turn promise into prosperity for the region while advancing human health.

BHI’s Entrepreneur-in-Residence (EIR) program is designed to be an active partner with research institutions to source, fund, and grow high-potential, early-stage products through project-focused companies. The entrepreneurs in the program support the formation of new companies based upon innovative discoveries in the areas of drugs, vaccines, therapeutics, diagnostics, and medical devices from the intramural research programs at the NIH and Food and Drug Administration (FDA), as well as from universities and businesses.

BHI's Commercial Relevance Program (CRP) offers biohealth companies support in preparing applications for federal funding inclusive of SBIRs, STTRs, and other federal government awards. Companies submit their federal funding concepts and receive pre-proposal feedback to help troubleshoot and strengthen your application. Further support from professional consultants and service providers is available to assist in improving your application.

BHI recently published the Central Maryland BioHealth Entrepreneur's Resource and Finance Guide 2013. The Guide serves as a compendium of resources to biohealth innovators and entrepreneurs working to start and grow new companies and technologies in the region.

The Partnering Agreements with United Therapeutics 2005-2013 report provides an in-depth insight into the partnering interests and activites of one of the worlds leading biopharma companies.

This report provides all the information you require to better understand United Therapeutics and its partnering interests and activities over the past seven years.

On demand company reports are prepared upon purchase to ensure inclusion of the most up to date deal and company data.

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received approval by the U.S. Food and Drug Administration (FDA) to market the therascreen EGFR test as a companion diagnostic to guide the use of Boehringer Ingelheim's new targeted therapy, GILOTRIFTM (afatinib), for treatment of metastatic NSCLC in patients whose tumors have certain EGFR gene mutations. More than 200,000 new lung cancer cases are diagnosed every year in the United States, with NSCLC accounting for approximately 85% of cases, leading to an estimated 160,000 deaths.

The therascreen EGFR test enables doctors to identify EGFR mutation-positive patients eligible for treatment with GILOTRIFTM (afatinib). The FDA approval of the therascreen EGFR test marks a further milestone in the global expansion of QIAGEN's Personalized Healthcare franchise - and adds a third FDA-approved or cleared diagnostic kit to run on QIAGEN's efficient Rotor-Gene Q MDx. Approximately 120,000 metastatic NSCLC patients each year in the U.S. could benefit from testing for EGFR mutations, a total potential testing market of about $35 million, according to QIAGEN estimates.

Bethesda tops a list of The Most Educated Places in America

Personal finance site NerdWallet Inc. ranked cities based on high school drop out rates and the percentage of the population with associate degrees, bachelor's degrees, master's degrees and professional or doctoral degrees.

Lower overall costs of occupancy — coupled with academic resources and an educated work force — have made clusters outside the nation's largest metro areas more attractive to multinational pharmaceutical companies focusing on right-sizing and R&D productivity. In the Midwest, Chicago remains an emerging cluster, while Minneapolis is holding steady as a top-10 cluster for the second year in a row. JLL’s second annual life sciences cluster report ranks top-10 cities for life sciences companies in 2013.

Innovation is a vague word and is too overused today, in the words of Bryan Sivak.

That was kind of a bold statement to make at a conference focused on, well, innovation.

In his keynote address at CONVERGE, the chief technology officer for the U.S. Department of Health and Human Services said the department’s philosophy is that innovation happens as a direct result of the freedom to experiment, a much more descriptive and meaningful phrase.

Kauffman Foundation FastTrac®, has joined with Montgomery College to support future and current business owners before, during, and after the startup process. Entrepreneurs will receive the information, resources, and networks necessary to start and grow successful businesses.

Three courses will be offered:

• FastTrac NewVenture
• FastTrac GrowthVenture
• FastTrac TechVenture

For more information: Program Flyer 

At the funding panel discussion Wednesday at CONVERGE, a serial entrepreneur asked about crowdfunding.

First we got the stock answer of “don’t see how it’s possible for healthcare companies.” Then the conversation turned to cap tables.

Elliott Menschik of Dreamit Ventures said that having 50-60 people on a cap table is becoming normal.

Microryza.com (not the catchiest of names) is a crowdfunding platform for research that raises money over the Internet from individuals who are willing to donate small amounts to fund a specific project. The average donation according to Microryza is $92.

In return for a 5 percent cut of funds raised and a 3 percent credit card processing fee, Microryza provides researchers access to a website where they can solicit money from the public to fund their research. Crowdfunding is typically an all-or-nothing deal, where donors only have to pay their pledged support if the project is fully funded within a defined period of time.

University of Maryland (UM) Ventures announced today a collaboration between Frank Robb, Ph.D., at the Institute of Marine and Environmental Technology, and Department of Microbiology & Immunology at the University of Maryland School of Medicine, and Rockville, Maryland-based Fina Biosolutions LLC to devise new ways to manufacture a key component used in many vaccines. The international nonprofit organization, PATH, which spurs new innovation with the goal of delivering high-impact, low-cost global health solutions such as lifesaving vaccines, will fund the partnership's development efforts as part of its pneumococcal vaccine project.

"A new and improved vaccine production method is the goal of this public-private partnership between my lab and Fina Biosolutions," said Dr. Robb. "It is designed to yield broader availability of an important vaccine component, which is highly effective, but prohibitively expensive for some applications, particularly in the developing world."

CMS has proposed a policy change that would expand payments for telehealth services under the Medicare Physician Fee Schedule for 2014, Modern Physician reports.

Details of the Proposal

The proposed change would affect locations identified as rural "health professional shortage areas."

Indiana University scientists have transformed mouse embryonic stem cells into key structures of the inner ear. The discovery provides new insights into the sensory organ's developmental process and sets the stage for laboratory models of disease, drug discovery and potential treatments for hearing loss and balance disorders.

A research team led by Eri Hashino, Ph.D., Ruth C. Holton Professor of Otolaryngology at Indiana University School of Medicine, reported that by using a three-dimensional cell culture method, they were able to coax stem cells to develop into inner-ear sensory epithelia -- containing hair cells, supporting cells and neurons -- that detect sound, head movements and gravity. The research was reportedly online Wednesday in the journal Nature.

The biotech IPO window is officially open.

Eleven second-quarter biotech initial public offerings totaling $1 billion — the strongest quarterly biotech market for venture-backed IPOs since third-quarter 2000 — fueled an overall surge in IPOs, according to the National Venture Capital Association and news and data company Thomson Reuters.

Even as the White House has backed off on a few of its deadlines for administering the Affordable Care Act, the Obama Administration is staying the course on its efforts to transition paper files to electronic health records in doctor's offices.

President Barack Obama met with several chief executives of health-care technology companies, government leaders and nonprofit public-service organizations on Monday for a conversation on how technology, big data and innovation can be used to bring down the costs and improve the quality of health care in the U.S., according to a statement from the White House.

The head of the nation's medical research agency and leaders of Johns Hopkins hospital and medical school warned Monday that progress in fighting diseases could be slowed, jobs lost and scientists driven overseas unless across-the-board federal funding cuts are reversed.

Dr. Francis Collins, director of the National Institutes of Health, joined Sen. Barbara A. Mikulski, Hopkins executives and a stroke survivor at Hopkins' Children's Center to appeal for restoration of $1.5 billion in NIH funding cuts as part of the budget "sequester" approved last winter by Congress.

A total of 150 investors are vying for Maryland’s biotechnology tax credit this year, compared with 125 applicants last year.

Maryland’s Biotechnology Investment Incentive Tax Credit program gives tax credits to individuals and companies that invest in Maryland-based biotechnology startups. The program will give out $10 million in tax credits for fiscal 2014.

Montgomery County's top biotechnology firms will open their doors and their state-of-the-art laboratories next week to local middle school students interested in the life sciences. In a partnership with MdBio Foundation, Inc., and Montgomery College, preeminent local scientists and executives from MedImmune, Qiagen and Emergent BioSolutions will share their expertise and career stories with students from the Young Science Explorers Program (YSEP), a weeklong science workshop for rising seventh and eighth grade students.

Dressed in lab coats and safety glasses, students will get once in a lifetime exposure to local companies and scientists on the leading edge of medical breakthroughs. Topics will range from microbiology and vaccine research to lab safety and potential career paths for science students.

Science Applications International Corporation (SAIC) SAI +0.46% , Maryland's Department of Business and Economic Development (DBED), and the University of Maryland, Baltimore County (UMBC) announced the third annual 2013 statewide cyber competition, the Maryland Cyber Challenge(TM), will be held October 8 through October 9 at the Baltimore Convention Center in Baltimore, Maryland. Registration is now open for aspiring cyber warriors from around the nation to compete at the Maryland event, located in the growing epicenter for the cybersecurity industry.

The Maryland Cyber Challenge(TM) is designed to attract more students and young professionals to pursue careers in cybersecurity and is held in conjunction with the CyberMaryland2013 Conference and Cyber Hall of Fame. It is the premier statewide cyber competition showcasing today's students and tomorrow's technologists with three levels of competition: high school, college and professional. Teams will have the opportunity to develop and improve their cybersecurity skills in a real-world environment. Founders of the event include SAIC, UMBC, DBED, the National Cyber Security Alliance (NCSA), and the Tech Council of Maryland (TCM).

Creating a new medical device is not an inexpensive exercise. There are development costs, clinical trial expenses, and the lengthy process of getting a piece of new equipment approved by the Food and Drug Administration.

Those hurdles are a leading reason why most medical innovations come out of universities or established research firms.

As investments in life science companies have dipped over the past few years, some investors have scaled back investments or walked away from the sector all together. But based on a tally by investment research firm PitchBook in its 2013 Venture Capital Healthcare Report, several firms have made 10 or more investments in pharmaceutical, medical device or health IT companies in the last year and a half.

Due to the many changes that will result from the SBIR/STTR Reauthorization Act, NIH has set up a new website to keep the small business research community informed.

Applicants and grantees interested in the SBIR program can visit the website as well as the SBIR listserv and Twitter feed for news as the implementation plan rolls out.

1776, the D.C. startup hub that launched earlier this year with District funding, plans to pull together a seed fund that will allow it to make equity investments in early-stage tech companies.

The creation of a fund would turn 1776 into a bona fide "accelerator." The 1133 15th St. NW space, run by Startup DC's Evan Burfield and Donna Harris, is now primarily a co-working operation (some say incubator), with additional programs layered on top of it, like the recently announced Challenge Cup international startup tournament.

Funding for digital health startups is continuing to grow at a steady pace, but is beginning to stabilize.

Health accelerator Rock Health’s midyear report, released today, found that digital health funding for the first half of 2013 represents 11 percent growth in investment and 24 percent growth in deals year over year. In short, it’s still growing, but not as fast as in previous years.

It’s been a slow year for startup fundraising—the investments doled out by venture firms in the first quarter dropped 6 percent compared with the same period of 2012. But at least a couple of sectors have been defying that trend. One is software, where funding for the first half of 2012 was up 38 percent over 2012 levels, and another is digital health, up 12 percent.

In a report issued yesterday (slides embedded below), San Francisco-based digital health accelerator Rock Health delved into the details behind that 12 percent number.

When health IT startups say they’re making a new technology platform for physicians, John Sung Kim has an immediate follow-up question – for what specialty?

That’s a question he learned was critical as he began building and trying to sell the platform developed by his first health startup, DoctorBase. It’s been a series of hits and misses, which Kim isn’t afraid to talk candidly about. In a recent interview, he explained to MedCity News one of the most surprising things he learned when he set out to build a mobile platform that would let doctors, administrators and patients communicate without having to pick up the phone.

It’s good to have friends in high places. Especially friends who can leverage more than 30 years of experience in technology and business to nurture and foster your startup seed.

1776, a new startup incubator based in Washington, D.C., just announced a brand-new partnership with Microsoft, in which leaders from the company will collaborate with startups to guide them from a technical and business standpoint.

“[Microsoft] will help startups to leverage platforms upon which they can build innovative apps with the ability to scale rapidly and efficiently,” says 1776 co-founder Donna Harris. “Through 1776, they're also providing mentorships for architects who can ensure that startups are maximizing the potential of these tools and platforms.”

Registration for the fall semester of Technology Transfer Classes at the FAES Graduate School at NIH is now open. For the semester beginning on September 9th there will be 12 courses offered in the technology transfer program:

· TECH 506 - Research Commercialization Webinar Course: The Essentials

· TECH 513A Introduction to Technology Transfer -- Issues and Processes (given by the Technology Transfer Society)

· TECH 521 - Tools for Technology Transfer

· TECH 565 - Biomedical Business Development for Scientists

· TECH 567 - International Strategic Partnering and Business Development

· TECH 579 - Introduction to Negotiation

· TECH 575 - Business Finance & Accounting Principles for Scientists

· TECH 583 - Patent Research for Non-Legal Practioners

· TECH 587 - Strategic Consulting for Tech Companies

· TECH 607 - Capstone Course in Technology Transfer

· PHAR 328 - FDA Perspective on Drug Development

· PHAR 500 - Principles of Clinical Pharmacology

More details can be found in the new 2013 course catalog (www.faes.org) with enrollment open to the general community. All classes are part of the "Advanced Studies in Technology Transfer" certificate program and can be fully transferred as a block into various MBA & MS degree programs at the University of Maryland University College (UMUC) Graduate School.

There will also be an open house for the FAES Graduate School on Tuesday, August 20th from 4-7pm at the new FAES Classroom & Bookstore complex in Building 10.

Notice of Change to Earliest Start Date for Applications Submitted to RFA-DA-14-002 "Short-term Mentored Career Enhancement Awards in the Basic Behavioral and Social Sciences: Cross-Training at the Intersection of Animal Models and Human Investigation (K18)"

On June 26, 2013, United Therapeutics Corporation (the "Company") held its 2013 annual meeting of shareholders. The Company's shareholders considered three matters, each of which is described in more detail in the Company's Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on April 30, 2013. The final voting results for the meeting are as follows:

1. The Company's shareholders elected the following nominees as Class II directors, to serve three-year terms until the 2016 annual meeting of shareholders or until their successors are duly elected and qualified or their office is otherwise vacated, by the votes set forth below:

Five years ago I built a biotechnology innovation index and I have been using it since tracking global biotechnology innovation in Scientific American’s Worldview. It has been a very rewarding project, and I have enjoyed the opportunity to present my research data at international conferences, business schools, and even National Defense University.

Now, Worldview’s editor Mike May has compared my innovation scores with the Venture Capital and Private Equity Country Attractiveness (VCPECA) index. I was quite pleased to see a relatively strong correlation between my innovation index and the VCPECA index.

We knew that biotech companies were lighting up the stock market this year. Today, the National Venture Capital Association has fresh numbers illustrating Wall Street’s love affair with life sciences entrepreneurs—and the corresponding cold shower awaiting their counterparts in the tech sector.

The new report, comparing venture-backed IPOs with merger-and-acquisition deals, shows life sciences companies accounting for 13 of the 21 public stock listings in the second quarter.

Revolution Ventures, the early-stage venture capital arm of Steve Case's Revolution LLC, has filed paperwork with the Securities and Exchange Commission for a planned $150 million fund. Named in the SEC filing are Case and managing partners Tige Savage and David Golden. Revolution Ventures II LP, as it's named in the filing, follows the formation in 2011of Revolution Growth, which invests in more mature, later-stage companies. Revolution Growth, led by Case, Donn Davis and Ted Leonsis, is operated separately from the venture unit.

Sources inform "Globes" that AstraZeneca plc (NYSE; LSE; OMX: AZN) has teamed with Israeli real estate company Minrav Holdings Ltd. (TASE: MNRV) to bid in the Office of the Chief Scientist's biotechnology incubator tender. AstraZeneca will handle the consortium's professional side, and Minrav will be responsible for financing.

The AstraZeneca-Minrav consortium is bidding against a consortium of OrbiMed Israel and the venture capital arms of Johnson & Johnson (NYSE: JNJ) and Japan's Takeda Pharmaceuticals Co. Ltd. (TSE: 4502).

New Enterprise Associates has increased its focus on companies developing drugs for rare disease, an effort that's paying off. Portfolio company Prosensa Holding BV, which it backed last year, has just gone public on Nasdaq. The company develops therapies for rare conditions such as Duchenne muscular dystrophy, myotonic dystrophy and Huntington's disease. 

Johns Hopkins Montgomery County has received the 2013 Visionary Award from the Montgomery County Chamber of Commerce.

Before an audience of hundreds at the Chamber’s Annual Awards Dinner, Campus Executive Elaine Amir thanked the Chamber for the recognition, thanked Montgomery County for having the foresight to establish the campus in 1985 and applauded County Executive Ike Leggett for his encouragement and support.